Skip to main content
OpenTrials
Completed

NCT Number: NCT04880733

Acupuncture in the Emergency Department for Pain Management

Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego, La Jolla, California, United States

Loading trial locations.

About this study

The goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will include the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), the investigators will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. Prior to the start of the RCT at all sites, study investigator meetings will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), the investigators will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Study outcomes include responsive manualization of acupuncture intervention, recruitment, retention, patient adoption, patient acceptability, and provider acceptability. Measures will be collected including pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥18 years of age
  • Ability to communicate in English.
  • Level 3, 4, 5 on triage rate scale
  • Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury.

Exclusion criteria

  • Fever exceeding 100° F
  • Presenting with a chief complaint of a psychological / psychiatric concern
  • Presenting with chief complaint of Migraine
  • Patient arriving via ambulance or skipping triage
  • Current Pregnancy
  • Self-reported opioid medication taken orally within 4 hours
  • Presenting with chief complaint of Joint Dislocation
  • Presenting with chief complaint of Bone Fracture
  • Confirmed or suspected COVID-19

Treatment and study plan

Acupuncture for pain management

Procedure

A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.

Usual care for pain management

Other

Patient will receive usual care for pain management.

Primary outcomes

  1. Successful Recruitment of Participants Into the Study.

    Time frame: At Enrollment

    The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.

Secondary outcomes

  1. Percentage of Participants Retained in the Study at Post Treatment

    Time frame: At post treatment (45-60 minutes)

    Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.

  2. Percentage of Patients Retained at 1-week Follow up

    Time frame: One-week after the participant was discharged from the ED

    Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.

  3. Patient Satisfaction Question 1 at Post-treatment

    Time frame: At post-treatment (45-60 minutes after baseline)

    Question 1: "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).

  4. Patient Satisfaction Question 2 at Post-treatment

    Time frame: At post-treatment (45-60 minutes after baseline)

    "Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).

  5. Patient Satisfaction Question 1 at 1-Week

    Time frame: One week after participant was discharged from the ED

    "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).

  6. Patient Satisfaction Question 2 at 1 Week

    Time frame: One week after participant was discharged from the ED

    "Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).

  7. Provider Satisfaction Question1

    Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).

    "Do you view acupuncture in general as an appropriate intervention for the ED setting?" on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better.

  8. Provider Satisfaction Question 2

    Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).

    "Do you view acupuncture in general as helpful in managing patient pain in the ED?" on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better.

  9. Provider Satisfaction Question 3

    Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).

    "How satisfied are you with the way that the acupuncture intervention was implemented in your setting" on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better

  10. Provider Satisfaction Que4

    Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).

    "Did the ACUITY project impose a burden on ED staff in your setting?" on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • Albert Einstein College of Medicine
  • University of California, San Diego
  • University of Massachusetts, Worcester
  • Vanderbilt University Medical Center

Registry information

Official study title

Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study

Acronym: ACUITY

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
May 11, 2021
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.